gbo Medizintechnik Sonostat User Manual page 31

Sonostat
In accordance with the EMC-regulations for medical products we are obliged by law to
provide the following information.
Guidance and manufacturer's declaration — electromagnetic emissions
The equipment is intended for use in the electromagnetic environment specified below. The
customer or the user of the equipment should assure that it is used in such an environment.
Emissions test
RF emissions,
CISPR 11
RF emissions,
CISPR 11
Harmonic emissions,
IEC 61000-3-2 (*)
Voltage fluctuation/flicker
emissions, IEC 61000-3-3 (*)
(*) Note: For devices with a power consumption between 75 W and 1000 W only.
Guidance and manufacturer's declaration — electromagnetic immunity
The equipment is intended for use in the electromagnetic environment specified below. The
customer or the user of the equipment should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD),
IEC61000-4-2
Electrical fast transient/burst,
IEC 61000-4-4
Surge,
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines,
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field,
IEC 61000-4-8
Note: U is the a.c. mains voltage prior to application of the test level.
gbo Medizintechnik AG
Compliance
Group 1
Class B
Class A
Complies
IEC 60601- test
level
6 kV contact
8 kV air
2 kV for power supply
lines
1 kV for input/output
lines
1 kV differential mode
2 kV common mode
<5% U
for ½ cycle
(>95% dip)
40% U
for 5 cycles
60% dip)
70% U
for 25 cycles
30% dip)
<95% U
for 5 s
(>5% dip)
3 A/m
Electromagnetic environment – guidance
The equipment uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The equipment is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Compliance
level
6 kV contact
8 kV air
2 kV for power supply
lines
1 kV for input/output
lines
1 kV differential mode
2 kV common mode
<5% U
for ½ cycle
(>95% dip)
40% U
for 5 cycles
60% dip)
70% U
for 25 cycles
30% dip)
<95% U
for 5 s
(>5% dip)
3 A/m
Electromagnetic
environment – guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that of a
typical commercial or
environment.
Mains power quality should be that of a
typical commercial or
environment.
Mains power quality should be that of a
typical commercial or
environment.
If the user of the equipment requires
continued operation during power mains
interruptions, it is recommended that the
equipment be powered
uninterruptible power supply or a
battery.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
31
hospital
hospital
hospital
from an
Version 1.2